The IRB Office processes the submitted protocol, inputs information into the database,
and assigns the protocol a unique IRB number. The protocol is assessed by the IRB
office for determination of the level of review. The protocol is then routed through
the appropriate review process. The IRB has available a flowchart on the IRB process which details the entire review process from beginning to end.

Your study will require a Full-board review if it involves vulnerable subjects such
as children, pregnant women, persons with disabilities, prisoners, and those who are
institutionalized. It may also require Full-board review if the research procedures
are particularly risky and have notable potential to harm a subject. Your protocol
may also require a Full-board review where disclosure of the participant's identity
might result in negative legal, financial, economic or social consequences. It is
best to candidly describe your research design and procedures and allow the IRB to
assess the level of review required.

There are four major areas of concern that are evaluated in determining whether participants'
rights and welfare are protected. They are 1) the design of the research, 2) the balance
of harm and benefit, 3) the process of informed consent, and 4) the selection of subjects.
The research design is considered for several reasons. For example, if a research
project is poorly designed, no valuable information is likely to be gained. Thus,
such a protocol cannot justify risks or inconveniences to the subject. This is part
of conducting the risk-benefit analysis. Another issue is that some individuals think
of "informed consent" as a document containing details of the research that is signed
by the subject. In the development of your research, think of informed consent as
a process. Informed consent means that the subjects truly understand what they are
agreeing to and all of the risks and benefits inherent in the activity.

Data collection instruments may be coded (i.e., insert number on paper), and the code
linked to a mailing list. As the survey instruments are returned the coded number
can be traced back to the mailing list. By matching the code to the mailing list,
the researcher will have a record of replies received while retaining anonymity. The
mailing list should be destroyed following data collection.

Non-affiliated researchers must seek approval from their institutional IRB first.
Next, depending on the nature of the research, the USA IRB can do several things:
1) Defer to the primary institution's IRB; 2) Require the non-affiliated researcher
to complete a USA IRB application and apply for approval according to USA's standard
operating procedures. If it is determined that the project requires an approval at
USA, the researcher will need to find an on-campus faculty member in the appropriate
discipline to endorse the project and to act as a liaison/contact for the project.
USA IRB will accept documented evidence of IRB training from other institutions.

If a class project is done with the intent to share information within a classroom,
IRB review is not required, because the federal regulations define "research" as a
systematic investigation, including development, testing, and evaluation, designed
to develop or contribute to generalizable knowledge. However, if you plan to publish
your data in any way (e.g. abstract, article, poster) or plan on sharing your data
outside of a classroom setting, then you should contact the IRB.

Yes, human blood, body fluids, tissue or waste specimen, human cell lines and non-human
primate cell lines need an IBC application and are handled at the BSL-2 level. In
some cases, the use of bloodborne pathogens may also need IRB approval. For further
information about the use of human subject or blood, and tissue from human subjects,
please contact the Office of Research Compliance and Assurance (ORCA). Additionally,
if a cell line that the PI creates and is a species that may harbor a zoonotic agent
then an IBC application is needed.

If it is a non-human/non primate line from a public-commercial company (e.g. one that
certifies reasonably healthy lines), a protocol may not be necessary. If it is a cell
line that the PI creates and is of a species that "could" harbor a zoonotic agent
then an IBC protocol would be needed.

If the hazardous materials are to be shipped, then certain about of training is involved
depending on what it is. There are two categories requiring differing levels of instruction,
the most stringent of which requires actual certification. It all depends on the risk
associated with the substance that you are shipping. USA has both trainings available
and tools to help you decide what category the hazardous substance fits in to. Training
materials and tools can be accessed by clicking here.

The fit tests are to be done annually for BSL-3 work and anytime there are changes
in the fit of the respirator, e.g. large weight gain or loss, facial injury/surgery.
The appropriate respirator will be selected for you, fit tested on you by a member
of Safety and Environmental Compliance (SEC) to ensure proper fit ad seal, and you
will be trained on the proper use and maintenance.

There is a form for the researcher to complete with the information specific to their
lab. That information is used to fill in the signs in to a software program and print
them out. Sign holders for the lab door signs can also be provided. Other templates
are available as well. e.g. the Satellite Accumulation Area signs. Contact Safety
and Environmental Compliance at 460-7070.

IBC registrations are handled in two different categories. Work with hazardous agents
requires a PI to fill out a Bio-hazard Registration Form. Any research being conducted
with recombinant DNA will require the rDNA Registration Form to be completed. It is
quite possible that one study can involve both activities. In that case, both forms
will need to be completed. Every three years the PI will receive a notice asking if
the study has changed, remained the same, or needs to be cancelled and the laboratory
will be inspected once a year by the IBC. At any time, amendments can be submitted.
All forms can be located on our Biosafety Page

The Occupational Safety and Health Administration (OSHA) requires individuals working
with bloodborne pathogens must undergo bio-safety training on a yearly basis. As per
our institutional policy, any PI with an approved registration from the IBC must undergo
that same training yearly. This also includes any associates that are listed in the
protocol. Training is located online at https://www.citiprogram.org/Default.asp. Reminders will be sent when it is time to renew.

EXPORT CONTROLS

An export is an actual shipment or transmission of any commodity (equipment or hardware)
out of the United States, or the release of technology (technical data or information)
about controlled commodities, or software (commercial or custom-made) to a foreign
national out of or within the United States.

It is very likely that you already own items that are one the Commerce Control List
(CCL). Computers, smart phones, MP3 players, GPS navigation systems, every day software
(Window operating systems),etc all have components included in the descriptions on
the CCL. Almost all are covered under a "mass market" exemption, but it shows how
diligent universities have to be with the equipment contained labs and the data being
collected. The potential to come across something "controlled" is unlikely.

A deemed export is the transfer, release, or disclosure to foreign persons in the
United States of technical data about controlled commodities. A transfer of "technology"
or "technical data" to the foreign person is "deemed" to be an export to the home
country of the foreign person. In non-government speak: If you are talking to someone
from a foreign country, you are considered to be exporting the information contained
in your discuss to where ever they are from. i.e. If you are having lunch at Panera
Bread with a friend from Germany, your conversation is "exporting" information to
Germany.

There are several exclusions, but two are particularly relevant to academic research:
the fundamental research exclusion and the public domain exclusion. These exclusions
can become void, if researchers make side agreements that contain publication restrictions
or restriction on who may participate in the research. Specifically,

Public Domain

publication in periodicals, books, print, electronic, or other media available for
general distribution (including websites that provide free uncontrolled access) or
to a community of persons interested in the subject matter, such as those in a scientific
or engineering discipline;

readily available at libraries open to the public or at university libraries;

patents and published patent applications available at any patent office; and

release at an open conference, meeting, seminar, trade show, or other open gathering
held in the U.S. (ITAR) or anywhere (EAR).

Education

exclusion for "educational information" released by instruction in catalog courses
and associated teaching laboratories. So, in general, no need for a license to share
information as part of a regular course being taught at USA.

Fundamental Research Exclusion (FRE)

Fundamental research is defined as basic and applied research in science and engineering
conducted at an accredited U.S. institution of higher education where the resulting
information is ordinarily published and shared broadly within the scientific community.

Possibly. Microsoft provides information on their website at http://www.microsoft.com/exporting/ (or at the home page, search for "export control") that lists their different hardware
and software products along with the DoC ECCN (export classification number) and the
status of this item relative to requirement of a license for export.

ANIMAL CARE AND USE

The Institutional Animal Care and Use Committee (IACUC) oversee the responsible use
of animals in University research and instructional activities, including field research.
The IACUC reviews protocols, reviews the animal care and use program, and monitors
University animal facilities to ensure compliance with institutional and federal standards
and regulatory requirements.

You will need to complete the specified training requirements, as well as, enroll
in the Occupational Health Program (OHP) before you are able to work with animals.
The training requirements can be found on the IACUC website, or by clicking here.

Anyone who works with animals must complete training and OHP. An OHP waiver may be
requested in circumstances where the named PI of the protocol does not plan to handle
the animal in the conduct of the planned animal research activity. These requests
require approval by the University's veterinarian.

Your training is only good for three years. The CITI on-line training program will
send you e-mail messages asking you to update your training, sixty days before it
expires. OHP participation is a one-time enrollment, except for those employees who
handle non-human primates and require continued medical surveillance.

USA uses a program called GRANITE to submit protocols. The IACUC Office provides a
guide on how to fill out a protocol on the IACUC website, or you can click here. There is also a tip sheet that the IACUC Office provides on the IACUC website, or
you can click here.

USA requires IACUC approval for work with live vertebrates. The IACUC must review
ALL projects involving the use of ANY vertebrate animals for ANY purpose (including,
but not limited to, biomedical and behavioral research, teaching, testing, field work
and exhibition projects) to ensure compliance with USA policies and federal regulations.
Even studies which involve no direct contact with vertebrate animals but which affect
animals through influencing or changing their habitat (e.g. observing the result of
outside stimulus on bird calls, observation of fish or wildlife after modifying their
habitat or interrupting their daily routine) must be submitted for the Committee's
consideration prior to initiation

Procedures are classified according to the level of potential pain or distress that
the animal may experience. If more than slight or momentary pain and distress could
be caused by the procedure, then relief must be provided (pain class B). If relief
cannot be provided (pain class C), there must be scientific justification for the
withholding of relief, the justification must be included in the animal use protocol,
and it must be approved by the IACUC. Additional information can be found in the USDA
Animal Care Resource Guide, Policy #11, Painful Procedures.

Multiple Major Survival Surgery: A major survival surgery penetrates and exposes the
body cavity or produces substantial impairment of physical or physiologic functions
(such as laparotomy, thoracotomy, craniotomy, joint replacement and limb amputation).
Scientific justification is required in the animal use protocol, if more than one
major survival surgery is to be performed on an animal during the course of the protocol
experiment.

The generation of custom antibodies is considered an activity involving vertebrate
animals and covered by PHS Policy. Antibodies are considered customized if produced
using antigen(s) provided by or at the request of the investigator (i.e., not purchased
off-the-shelf). An organization producing custom antibodies for a grantee must have
or obtain an assurance, or be included as a component of the grantee's assurance.
In addition, the applicant must provide the date (verification) of project-specific
IACUC approval for the production of the antibodies.

If the animals are specifically raised for you, then you need a protocol. If you are
obtaining animals or tissue that was already dead then you do not need an IACUC protocol.
However, the IACUC requires you to submit a brief memo, if obtaining commercially purchased (i.e. grocery store, slaughterhouse, Carolina Biological, etc) animal tissue. The
memo needs to be received by the IACUC office before the animal tissue is purchased.
The information to be disclosed is available here.

You should contact either the IACUC Office or the Department of Comparative Medicine's
veterinarian as soon as possible. The University veterinarian or the IACUC chairperson
will determine whether an amendment or a new protocol is required.

By federal law and University policy, Investigators are required to notify the committee
of any changes made to an active protocol. Typical modifications may include addition/removal
of personnel, numbers and species of animals, modifications to the experimental methods
or procedures, special requirements for animal husbandry and housing, etc.

es. When protocols are approved, the number of animals to be used in the studies covered
by that protocol is also approved. The Department of Comparative Medicine (DCM) tracks
the number of animals used and assesses charges for their care based on the protocol
to which they are assigned. Neglecting to transfer animals from one protocol to another
may risk exceeding quota for on-going studies. Moreover, DCM needs to know in which
studies the animals are involved to be able to provide appropriate veterinary care
if needed. Animals can be readily transferred from one of your protocols to another
by contacting DCM.

CONFLICTS OF INTEREST AND CONFLICTS OF COMMITMENT

A conflict of interest exists when an employee's financial or personal considerations may compromise, or
have the appearance of compromising, an employee's personal judgment in administration,
management, instruction, research, and other professional and academic activities.

A conflict of commitment exists when professional service or research contracted outside the University interferes
with the employee's paramount obligations to students, colleagues, and the primary
missions of the University.

A financial conflict of interest is a situation in which people might perceive that
your financial relationships may compromise your professional judgment in conducting,
analyzing, or reporting research or scholarly activities. Therefore, individual units/departments
reviews and manages these arrangements to protect the integrity of the research, institution,
and individual. Example: An investigator may have a financial conflict of interest if he or she is
a consultant to the company sponsoring research in his or her laboratory. Example: A faculty member owns significant equity in a company whose product he or
she wants to test.

The University requires faculty and administrative staff in a director position or
above to submit an annual disclosure or as well any new activity on an ad hoc basis
in order to eliminate or minimize their impact on any professional or research activity.
This policy requires disclosure of all interactions that involve any amount of Financial
Interest on the part of each Employee or Employee's Family as well as of all interactions
that could be reasonably perceived to bias any professional or research activity.

If it is determined that a financial conflict of interest or conflict of commitment
exists, a Conflict Management Plan is created in order to manage, reduce, or eliminate
the conflict. Management plans are reviewed, approved, and annually monitored by the
departmental chair as required by university policy. Conflict management plans should
be renewed annually and are effective as long as the conflict is present.

The decision of the departmental chair or College Dean or Institute Director may be
shared with University officials as deemed necessary. In cases relating to projects
involving human subjects, the recommendation will be shared with the IRB. It may also
be shared with the research sponsor if requested. Other than mandated disclosures
or limited internal disclosures, the information is treated as confidential.

The following might appear to involve a Financial Conflict of Interest but in fact
do not. Such activities do not require disclosure or administrative review:

Employees receiving royalties from the publication of books or for the licensure of
patented inventions subject to the Patent and Copyright Policies of the University.

Employees owning or having equity interest in a company, the exclusive function of
which is to accommodate the Employee's external research or consulting activities.

Employees receiving nominal compensation, in the form of honoraria or expense reimbursement,
in connection with service to professional associations, service on review panels,
presentations of scholarly work, and participation in accreditation reviews

RESEARCH MISCONDUCT

The University policy for Responding to Allegations on Research Misconduct describes the procedures followed when an allegation is made. Additionally, where
Public Health Service (PHS) funding is involved, Federal Regulations at 42 CFR 50
apply. Other agencies, such as the National Science Foundation, also have research
misconduct policies.

The University of South Alabama has adopted the definition of misconduct as stated
by the Office of Science and Technology Policy (OSTP): Research misconduct is defined
as fabrication, falsification, plagiarism in proposing, performing, or reviewing research,
or in reporting research results. Research misconduct does not include honest error
or differences of opinion. This definition applies to all research activities regardless
of funding source.

At any time, an employee may have discussions and consultations about concerns of
possible research misconduct with their immediate supervisor, college/school dean
or institute director, Research Integrity Officer or other University administrative
officials. The identity of confidential sources will be protected to the extent consistent
with the needs of an inquiry or investigation.

While anonymous allegations will be accepted, it is often difficult, if not impossible
to investigate a matter without the source of the allegations becoming obvious. For
this reason, among others, anonymity cannot be assured. Often, if anonymity is required,
an ongoing investigation gets to a point where it cannot proceed and must be abandoned
because more information is needed but cannot be obtained. An anonymous source cannot
be informed of the status or outcome of an investigation.

If the allegations appear to have merit and there is evidence of wrongdoing, the Deciding
Official (VP for Research) will appoint an ad hoc committee composed of three persons.
The Deciding Official will select the ad hoc committee members on the basis of scientific
expertise that is pertinent to the matter.

Depending on the severity of the misconduct, sanctions will vary. Recommendations
for sanctions are made by the Standards in the Conduct of Research Committee and referred
to the appropriate University officials.

RESPONSIBLE CONDUCT OF RESEARCH

RCR includes most professional activities that are part and parcel of a research career
and that are coming under increasing regulatory scrutiny. As defined by federal agencies,
RCR encompasses the following nine areas: research misconduct, human participants,
research involving animals, data acquisition, management, sharing, and ownership,
mentor/trainee responsibilities, publication practices and responsible authorship,
peer review, collaborative science, and conflicts of interests.

To comply with the Congressional mandate under the America COMPETES Act (applies to
NSF awards), NIH policies for training grants and career development awards, and to
demonstrate USA's commitment to providing the highest quality education for all students
and scholars. Instruction in the Responsible Conduct of Research is fundamental in
the preparation of our future scientists and engineers.

The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education,
and Science Act of 2007 or America COMPETES Act was enacted to ensure our nation's competitive position in
the world through improvements in math and science education and a strong commitment
to research.

Because USA is committed to providing the highest quality education for all students and scholars and believes that instruction in the Responsible Conduct of
Research is essential to encouraging and producing the best scientists and researchers
for the future.

The Office of Sponsored Programs certifies that USA has implemented an RCR training
plan when signing grant applications submitted to NSF. The PI will be responsible
for informing new hires of the requirements. The Office of Research Compliance and Assurance (ORCA) will have to access to data
available from the approved RCR training options and NSF funded research personnel.
ORCA will review the data on a quarterly basis for compliance and notify PIs of non-compliance.
ORCA will make this data available upon request from NSF or individual faculty member.

The online CITI training certification is transferable for components that are shared
among institutions. If additional training is required, which is dependent on level
of education, other requirements specific to USA are not transferable. Regardless
of other RCR training, new trainees will need to take approved courses or the online
training offered through USA. Training from other institutions will not be accepted.

The USA RCR training plan is being tailored to meet the needs of the individuals and
the career stage of those who participate in research. We believe a graduated, tiered
approach is the best solution to meet these needs.

No, the Postdoctoral Mentoring requirement is a separate initiative requiring the
submission of a mentoring plan that is described in a supplemental document specific
to each proposal submission. The plan is considered during the merit review process.
Guidelines for addressing mentoring plans within grant applications are available
on the Research Compliance and Assurance website.

Online training needs to be completed within 90 days of hire. Interactive training
for graduate students or postdoctoral researchers is required during the first year
of conducting research. At this time, USA has not defined a training expiration period.

Yes, CITI provides a certificate upon completion. Those records are also sent to ORCA.
The PI should expect to be contacted quarterly as to the names of those individuals
newly hired. ORCA will then verify those individuals have completed training by access
the completion records.

Documentation of the online CITI training should be maintained by the student and
the PI. If the activity is sponsored research, then documentation should be maintained
for a minimum of three years. The Office of Research Compliance and Assurance will
be responsible for monitoring compliance with the institutional plan. For NSF sponsored
research activities, the Office of Grants Administration requires RCR training documentation
as part of the close-out process.